Regulatory Compliance Monitor

Job ID: req2623
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

KEY ROLES/RESPONSIBILITIES

• Provides clinical trials monitoring for Phase I-III single site to large networks of clinical sites participating in Investigational New Drug (IND) and non-IND protocols
• Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs, Investigational Device Exemptions (IDEs), ICH/GCP guidelines, and other applicable regulations
• Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Critically evaluates clinical trial data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans
• Provides assistance with and monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution and the processing and disposal of returned investigational agents according to the study monitoring plans and Standard Operating Procedures (SOPs)
• Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) as needed and other CRAs
• Assists the clinical investigators and teams to reinforce and enhance a GCP culture
• Conducts risk assessment review of protocols to identify issues that must be monitored to ensure regulatory compliance
• Creates a monitoring and/or auditing process to address areas identified by the risk assessments related to research compliance areas for the IC
• Works with PIs and research teams to develop and understand risk-based monitoring plan for protocols under Investigational New Drug (IND)/Investigational Device Exemption (IDE)
• Conducts site visits before, during, and after initiation of clinical trials
• Reviews protocol and Informed Consent Forms (ICFs)
• Assists the clinical investigators
• Coordinates monitoring activities of clinical studies for domestic sites including conducting site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol, SOPs, International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), NIAID Institutional Review Board (IRB), other IRBs and NIH policies, and applicable regulatory requirements
• Assists other CRAs and Project Managers in the development of team processes and study-related documents
• Assists with ensuring required approvals are in place to initiate intramural research
• Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts
• Reviews or helps create internal and/or external SOPs, guidelines, and tools
• Travels to local, domestic, and possible international clinical sites as assigned
• Maintains Essential Documentation File contents and reconciliation of the documentation including ensuring all required essential study documents are current, complete, and accurate
• Ensures applicable Clinical Trial Database Systems are updated in a timely manner
• Assesses the completeness of regulatory files (IRB Approval, Informed Consent Forms and other FDA required documentation)
• Generates reports which provide information on the progress of the protocol and identifies any issues relating to regulatory compliance and policies, standards, and procedures
• Recommend improvements to procedures, standard operating procedures (SOPs) and guidance, recordkeeping, and training
• Reports issues related to noncompliance and recommendations to resolve them to the Office of the Clinical Director and PIs
• Disseminate expertise and best practices related to Human Protections in clinical research through presentations, publications, and /or interactions with colleagues
• Develops and implements systems for tracking and trending findings
• Develops and conducts focused education and training based on findings from risk assessments and monitoring/audits, enforcement activities, and new policies and regulations
• Assists with the development of NIDDK SOPs for monitoring and evaluating regulatory compliance for clinical research and quality assurance activities
• Attend meetings of various HRPP groups within NIH, including ORSC, QAPAC, etc.
• This position is located in Bethesda, MD

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of five (5) years of progressively responsible experience in biomedical research
• Experience must include a minimum of one (1) year directly related to overseeing multiple concurrent trials for clinical research associate positions. Nephrology, Endocrinology, Gastroenterology, or Metabolic experience may be preferred in support of certain programs as designated by the Program requirements
• Mastery of FDA regulations/guidance, ICH GCP E6, and best practice that govern clinical research
• Mastery of advanced management and organizational principles and practices to plan, implement and track complex clinical research protocols encompassing a broad range of medical specialties conducted in numerous Institutes
• Ability to work in a clinical research regulatory setting, both independently and with a team, to coordinate, negotiate and facilitate program goals, mitigate potential problems, move projects forward expeditiously, and meet deadlines
• Ability to interact with a broad range of senior scientific, medical and management staff, expert advisors, and representatives of other Federal and non- Federal organizations
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Excellent interpersonal, analytical, organizational and time management skills
• Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks/projects
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience if Diabetes and Digestive and Kidney Diseases
• Expert knowledge of the NIH organization mission, structure, scientific policies, and functions to design, coordinate and oversee complex special assignments of a sensitive or confidential nature
• Knowledge of Department of Health and Human Service (DHHS) regulations is a plus
• Experience with the development of manual of operations and study monitoring plans
• Knowledge of conducting federally funded studies
• Remote monitoring experience
• Ability to read French or Spanish
• ACRP Certified CRA or SOCRA Certified Clinical Research Professional
• Knowledge of international regulatory requirements

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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